FDA.reportPublic FDA data

Tinted Lip Sunscreen

Manufacturer
Scottsdale Skin Boutique and Dermatology Pllc | Fragrance Manufacturing Inc | Custom Analytics LLC
Effective date
2025-05-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:41

Label at a glance#

ProductTinted Lip Sunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product labelProduct label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85331-212-45Tinted Lip Sunscreen4.5 g in 1 BOTTLE, PUMPSTICK4.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85331-212TINTED LIP SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) STICK [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC]1Current NDC, 1 package rows20250510_34a5a99f-9e22-52ab-e063-6294a90a9323.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85331-21285331-212-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINGIBER OFFICINALE (GINGER) ROOT OILSAS9Z1SVUKIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX42DG15CHXVIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
CERESINQ1LS2UJO3AIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
ZINC OXIDESOI2LOH54ZACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALUMINALMI26O6933IACT
PEG-8B697894SGQIACT
TOCOPHEROLR0ZB2556P8IACT
CITRIC ACID2968PHW8QPIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
HEXYLDECANOL151Z7P1317IACT
CI 77492EX438O2MRTIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
ETHYLHEXYL PALMITATE2865993309IACT
FLAVOR SPICE MINT N&A110589KG6KU384XWIACT
STEARIC ACID4ELV7Z65APIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTERR6G12EY23XIACT
CI 77499XM0M87F357IACT
HEXYLDECYL LAURATE0V595C1P6MIACT
CI 774911K09F3G675IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
ndc (package): 85331-212-45
ndc (product): 85331-212
ndc11 (package): 85331021245
spl id: 34a5a99f-9e23-52ab-e063-6294a90a9323
spl set id: 34a5a99f-9e22-52ab-e063-6294a90a9323

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.